Overactive Bladder Syndrome
Conditions
Keywords
Bladder, Urinary Urgency, Solifenacin, Vesicare(R)
Brief summary
Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performance of clinical research in this field. The cause of urinary urgency is not fully understood and may vary from patient to patient. Although clinicians regularly obtain measures of bladder sensation during cystometry, little attention has been paid to the patient experience of urinary urgency. In this study, the researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary urgency in women with overactive bladder.
Detailed description
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 'no urge at all' to 100 'maximum urge which you can tolerate'. The testing is stopped once the bladder is filled. To minimize the chance of infection, participants receive one dose of oral antibiotics prior to the bladder testing. Following completion of the bladder test, participants will take 10mg solifenacin succinate (VesicareR) daily for 30 days. Afterward, participants repeat the bladder test. The change in participants' maximal tolerated cystometric capacity (MCC) will be measured in milliliters and used to evaluate the effectiveness of the drug.
Interventions
DRUGSolifenacin Succinate
Participants take 10mg daily solifenacin succinate for 30 days
Sponsors
Astellas Pharma Inc
Loyola University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment with anticholinergic medication. * Demonstrated detrusor overactivity with or without incontinence during urodynamic testing. * Are able to consent and fill out study documents, complete repeated urodynamic testing, and follow-up in 4 weeks.
Exclusion criteria
* Have been treated with any anticholinergic medication in the previous month. * Have an elevated post -void residual volume as determined during their routine clinical care. * Have had a urinary tract infection in the last month, as determined by history. * Have untreated narrow angle glaucoma, by patient history. * Have a known allergy or intolerance to solifenacin, as determined by patient history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximal Cystometric Capacity (mL) | 30 Days | At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug. |
Countries
United States
Participant flow
Recruitment details
Fifty-one individuals were consented and 42 women with overactive bladder (OAB) received study drug between January 2007 and February 2009. Participants were recruited using physician solicitation.
Pre-assignment details
Following informed consent, nine women were negative for OAB and did not receive solifenacin succinate
Participants by arm
| Arm | Count |
|---|---|
| Detrusor Overactivity Incontinence (DOI) Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI) | 18 |
| Urodynamic Stress Incontinence (USI) Patients in this cohort were diagnosed with urodynamic stress incontinence (USI) | 15 |
| Mixed Incontinence (DOI-USI) Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI) | 9 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 10 | 9 |
Baseline characteristics
| Characteristic | Detrusor Overactivity Incontinence (DOI) | Urodynamic Stress Incontinence (USI) | Mixed Incontinence (DOI-USI) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 0 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 11 Participants | 9 Participants | 34 Participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 9 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 15 | 0 / 9 |
| other Total, other adverse events | 0 / 18 | 0 / 15 | 0 / 9 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 | 0 / 9 |
Outcome results
Primary
Change in Maximal Cystometric Capacity (mL)
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.
Time frame: 30 Days
Population: The primary outcome analysis population comprises only women with two valid MCC recordings (i.e., one baseline recording and one recording following 30 days of treatment with daily 10mg solifenacin succinate. The groups DOI and USI were combined for this repeated measures analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline Maximal Cystometric Capacity | Change in Maximal Cystometric Capacity (mL) | 95 milliliters (mL) |
| One Month Maximal Cystometric Capacity | Change in Maximal Cystometric Capacity (mL) | 473.50 milliliters (mL) |
Comparison: The null hypothesis is that there is no change from baseline maximal tolerated cystometric capacity following 30 days of treatment with daily 10mg solifenacin succinate.p-value: 0.005Wilcoxon signed rank test